BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 21X1 RB

    MDR report key: 21909693 · Received April 25, 2025

    Report

    Report Number
    1911916-2025-00309
    Event Type
    Malfunction
    Date Received
    April 25, 2025
    Date of Event
    April 15, 2025
    Report Date
    May 9, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903051657
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR(B)(4) FOLLOW UP FOR DEVICE EVALUATION A LEAK WAS REPORTED AT THE BASE OF THE NEEDLE'S PLASTIC END. TO SUPPORT THE INVESTIGATION, ONE UNPACKAGED SAMPLE WAS SUBMITTED FOR EVALUATION BY OUR QUALITY TEAM. UPON VISUAL INSPECTION, A VOID WAS IDENTIFIED IN THE MOLDING APPROXIMATELY 5/16" FROM THE BASE OF THE NEEDLE HUB. THE SAMPLE WAS ASSEMBLED WITH A SYRINGE CONTAINING SALINE SOLUTION, AND LEAKAGE THROUGH THE MOLDING VOID WAS CONFIRMED. NO ADDITIONAL DEFECTS OR IRREGULARITIES WERE OBSERVED. THIS CONDITION IS TYPICALLY ASSOCIATED WITH IMPERFECTIONS IN THE STRIPPING BUSHING. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR MATERIAL NUMBER 305165, LOT 3347656. THE REVIEW DID NOT REVEAL ANY QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. NO RELATED QUALITY NOTIFICATIONS WERE IDENTIFIED. ALL MANUFACTURING PROCESSES AND FINAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH SPECIFICATION REQUIREMENTS. THE SAMPLE WILL BE SHARED WITH PRODUCTION ASSOCIATES TO RAISE AWARENESS. TO DATE, NO OTHER SIMILAR INCIDENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND ANALYSIS OF THE RETURNED SAMPLE, THE CUSTOMER-REPORTED ISSUE HAS BEEN CONFIRMED.

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    MATERIAL #305165, LOT #3347656. IT WAS REPORTED BY CUSTOMER THAT LEAK AT THE BASE PLASTIC END OF THE NEEDLE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. AS PER ACCOUNT, I WANTED TO REPORT A DEFECT WITH ITEM PRODUCT NUMBER 308-305165 (21G 1IN NEEDLE ONLY). THERE WAS A SIGNIFICANT LEAK AT THE BASE PLASTIC END OF THE NEEDLE. PLEASE SEND A REPLACEMENT FOR THIS ITEM AND INFORM XXXX CANADA INC OF DEFECT. ADDITIONAL INFORMATION: THE EXACT DATE THE EVENT OCCURRED WAS 15 APR 2025. I DO HAVE THE DEFECTIVE PRODUCT IN MY POSITION AND AM ABLE TO RETURN IT. YOU CAN SHIP THE RETURN LABEL TO (B)(6) OR EMAIL IT TO ME, AND WE CAN PUT IT IN AN ENVELOPE WITH THE LABEL TO SHIP OUT. THERE WAS NO HARM TO THE PATIENT OR CAREGIVER. THE DEFECT WAS NOTICED WHILE TRYING TO RECONSTITUTE MEDICATION, AND THERE WAS ONLY SALINE DRAWN INTO THE SYRINGE AT THE TIME (SO NO LOSS OF MEDICATION). OUR NURSE NOTICED THE DEFECT, BAGGED IT FOR ME, AND USED A NEW ONE TO CONTINUE RECONSTITUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1325958 NEEDLE 21X1 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 3347656 30382903051657

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown